(273 days)
No
The device description and performance studies focus on the physical properties and functionality of a ureteral stent, with no mention of AI or ML.
Yes.
The device is specifically designed to stent the ureter and provide drainage of urine, which is a therapeutic intervention aimed at treating medical conditions related to urine flow or ureteral support.
No
The descriptions of the Bander Ureteral Diversion Stent Set and the Dretler Ureteroscopy Stent Set indicate their use for drainage and stenting of the ureter. They are therapeutic devices designed to maintain patency and flow, not to diagnose a condition.
No
The device description clearly details physical components made of silicone and polyurethane, including stents, wire guides, adapters, and retainers. Performance studies also focus on physical properties and compatibility. There is no mention of software as a component or function of the device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for intraoperative placement to stent the ureter and provide drainage of urine. This is a direct medical intervention within the body, not a test performed on samples taken from the body.
- Device Description: The description details physical components like stents, wire guides, and adapters, all designed for insertion and manipulation within the urinary tract. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Anatomical Site: The anatomical sites mentioned are the ureter and kidney, which are internal organs where the device is physically placed.
- Performance Studies: The performance studies listed (MRI Safety, Dimensional, Tensile Strength, Flow Rate, etc.) are all related to the physical properties and functionality of the device within the body, not to the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis. It is a medical device used for a therapeutic and drainage purpose.
N/A
Intended Use / Indications for Use
The Bander Ureteral Diversion Stent
The Bander Ureteral Diversion Stent Sets are used for intraoperative placement to stent the ureter and provide drainage of urine from the kidney to the external stoma during ureteroileal conduit construction and continent urinary diversions.
The Dretler Ureteroscopy Stent
The Dretler Ureteroscopy Stent Set is intended to be used for post-ureteroscopy stenting of the ureter.
Product codes (comma separated list FDA assigned to the subject device)
FAD
Device Description
The Bander Ureteral Diversion Stent
The Bander Ureteral Diversion Stent Set features a pigtail ureteral stent constructed of either silicone or polyurethane. The stent ranges from 4.7 to 8.4 French and the overall lengths range from 70 to 90 centimeters. The pigtail retention coil can be open or closed, tapered or nontapered, but all configurations contain 6 evenly space sideports continue for the first 10 centimeters of the stent body from the pigtail. In addition to the 90° rotated sideports, some of the stents feature ink markings to aid in placement.
The Bander Ureteral Diversion Stents Sets are supplied with either one or two stents. When two stents are included, a right and left are color-coded red and blue, respectively.
The Bander Ureteral Diversion Stent Sets are also supplied with a straight wire guide.
The accessories supplied with the Bander Ureteral Diversion Stent Sets include an adapter with an O-ring and a catheter retainer.
The Dretler Ureteroscopy Stent
The Dretler Ureteroscopy Stent Set includes a 4.7, 6.0, or 8.4 French stent is manufactured using a polyurethane material and has a single pigtail at the distal end with 3 evenly spaced sideports. The stent comes with incremental ink markings and is 125 centimeters in length.
The Dretler Ureteroscopy Stent Sets are supplied with an accessory connector with an O-ring and a wire guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter, kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters on both subject devices. These tests include:
- MRI Safety Testing
- Dimensional
- Tensile Strength
- Shaft and Curl Elongation
- Retention Strength
- Flow Rate
- Radiopacity
- Kink
- Compatibility with components
- Artificial Urine Soak
- Accelerated Aging
The results of these tests show that the subject devices, Bander Ureteral Diversion Stent Set and Dretler Ureteroscopy Stent Set, met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the Bander Ureteral Diversion Stent Set is substantially equivalent to the predicate device the Percuflex™ Urinary Diversion Stent Set (K830803).
Furthermore, the results of these tests show that the subject Dreteroscopy Stent Set met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the subject Dretler Ureteroscopy Stent Set is substantially equivalent to the predicate device, the PercuflexTM Urinary Diversion Stent Set (K830803).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the Cook Medical logo, which is a white "COOK" on a red background, with the word "MEDICAL" underneath. Below the logo, the text "510(k) Summary" is displayed in a larger, bold font. The logo and text are centered.
COOK INCORPORA 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
K181971 Bander Ureteral Diversion Stent Set Dretler Ureteroscopy Stent Set 21 CFR $807.92 Date Prepared: April 4, 2019
Submitted By:
Applicant: Primary Contact: Secondary Contact: Applicant Address:
Primary Contact Number: Secondary Contact Number: (812) 335-3575 x105147 Contact Fax Number:
Cook Incorporated Paul Meyer Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x105299 (812) 332-0281
Device Information:
| Trade Name: | Bander Ureteral Diversion Stent Set
Dretler Ureteroscopy Stent Set |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | Ureteral stent |
| Classification Name: | Ureteral stent, |
| Regulation: | 21 CFR §876.4620 |
| Product Code: | FAD, Class II |
Predicate Device:
The Percuflex™ Urinary Diversion Stent Set (K830803, Boston Scientific) is designed to be used following percutaneous, endoscopic, or operative procedures. The design features a pigtail curl on the distal end to prevent migration and a luer-lock connection on the proximal end. The stent has graduation markings to aid in placement. The set includes two stents (color-coded left and right sides), a guidewire, catheter adapters, and a drainage bag connector.
De vice Description:
The Bander Ureteral Diversion Stent
The Bander Ureteral Diversion Stent Set features a pigtail ureteral stent constructed of either silicone or polyurethane. The stent ranges from 4.7 to 8.4 French and the overall lengths range from 70 to 90 centimeters. The pigtail retention coil can be open or closed, tapered or nontapered, but all configurations contain 6 evenly space sideports continue for the first
1
K181971 Page 2 of 6
10 centimeters of the stent body from the pigtail. In addition to the 90° rotated sideports, some of the stents feature ink markings to aid in placement.
The Bander Ureteral Diversion Stents Sets are supplied with either one or two stents. When two stents are included, a right and left are color-coded red and blue, respectively.
The Bander Ureteral Diversion Stent Sets are also supplied with a straight wire guide.
The accessories supplied with the Bander Ureteral Diversion Stent Sets include an adapter with an O-ring and a catheter retainer.
The Dretler Ureteroscopy Stent
The Dretler Ureteroscopy Stent Set includes a 4.7, 6.0, or 8.4 French stent is manufactured using a polyurethane material and has a single pigtail at the distal end with 3 evenly spaced sideports. The stent comes with incremental ink markings and is 125 centimeters in length.
The Dretler Ureteroscopy Stent Sets are supplied with an accessory connector with an O-ring and a wire guide.
Intended Use :
The Bander Ureteral Diversion Stent
The Bander Ureteral Diversion Stent Sets are used for intraoperative placement to stent the ureter and provide drainage of urine from the kidney to the external stoma during ureteroileal conduit construction and continent urinary diversions.
The Dretler Ureteroscopy Stent
The Dretler Ureteroscopy Stent Set is intended to be used for post-ureteroscopy stenting of the ureter.
2
Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, large, sans-serif font, and the word "MEDICAL" is in white, smaller, sans-serif font.
Comparison to Predicates:
The Bander Ureteral Diversion Stent Set
| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| Percuflex™ Urinary Diversion | |||
| Stent Set (K830803) | Bander Ureteral Diversion Stent Set | ||
| (Subject of this Submission) | |||
| Manufacturer | Boston Scientific | Cook | |
| Regulation Number | Unclassified | 21 CFR §876.4620 | |
| Product Code | LJE | FAD | |
| Classification Name | Catheter, Nephrostomy | Stent, Ureteral | |
| Device Class | II | Identical | |
| Indications for Use | The Percuflex™ Urinary Diversion | ||
| Stent Set is used for drainage | |||
| following percutaneous, endoscopic, | |||
| or operative procedures.* | Used for intraoperative placement to | ||
| stent the ureter and provide drainage | |||
| of urine from the kidney to the | |||
| external stoma during ureteroileal | |||
| conduit construction and continent | |||
| urinary diversions. | |||
| Model Number | M0061602XX | 025XXX[-XX] | |
| Kit Components | Stent Wire guide Catheter Connectors* Tube Connectors* | Stent Wire guide Drainage tube adapter Stent retainer | |
| Stent | Outer Diameter (Fr) | Pediatric: 4.0, 5.0, 6.0 | |
| Adult: 6, 7, and 8 | Adult: 4.7, 6.0, 7.2, and 8.4 | ||
| Length (cm) | Pediatric: 30 | ||
| Adult: 70 | Adult: 70, 75, and 90 | ||
| Material | C-Flex Thermoplastic Elastomer | silicone or polyurethane | |
| Tip Configuration | Closed and Open Tip | Identical | |
| Sideport Size (gage) | Unknown | Curl: 18, 19, or 21 | |
| Shaft: 17, 18, or 21 | |||
| Ink | Unknown | Black Ink | |
| Indwelling Time | ≤ 90 days* | ≤ 90 days | |
| Packaging | Unknown | Tyvek polyethylene peel-open pouch | |
| Sterilization | Unknown | EtO | |
| Shelf Life | Unknown | 3 years |
- If information was not specified within the predicate 510(k), then information was obtained from currently available marketing information and is discussed further in the Substantial Equivalence discussion as appropriate. See AppendixF for predicate marketing data.
The subject device, the Bander Ureteral Diversion Stent Set is similar to the Percuflex™ Urinary Diversion Stent Set (K830803, Boston Scientific) in terms of intended use and technological characteristics. The minor differences from the predicate devices include:
- Similar but not identical indications for use
- Product Code ●
- Additional stent dimensions ●
- Different stent materials
- Indwell time ●
- Packaging ●
3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, and the word "MEDICAL" is written in white below the word "COOK".
K181971 Page 4 of 6 NWW.COOKMEDIC.
- Sterilization ●
- Shelf-life ●
Reference devices used to help support a substantial equivalence determination for the Bander Ureteral Diversion Stent include:
- Cook Black Silicone Filiform Double Pigtail Stent Set (K172017) ●
- Surgitek Urinary Diversion Stent (K800109) ●
- Bard Ureteral Stent (K823487) ●
The Dretler Ureteroscopy Stent Set
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| Percuflex™ Urinary Diversion | ||
| Stent Set (K830803) | Dretler Ureteroscopy Stent Set | |
| (Subject of this Submission) | ||
| Manufacturer | Boston Scientific | Cook |
| Regulation Number | Unclassified | 21 CFR §876.4620 |
| Product Code | LJE | FAD |
| Classification Name | Catheter, Nephrostomy | Stent, Ureteral |
| Device Class | II | Identical |
| Indications for Use | The Percuflex™ Urinary Diversion | |
| Stent Set is used for drainage | ||
| following percutaneous, | ||
| endoscopic, or operative | ||
| procedures.* | Used for post-ureteroscopy stenting of | |
| the ureter. | ||
| Model Number | M0061602XX | 0255XX[-XX] |
| Kit Components | • Stent | |
| • Wire guide | ||
| • Catheter Connectors* | ||
| • Tube Connectors* | • Stent | |
| • Wire guide | ||
| • Catheter adapter | ||
| Stent Outer Diameter | ||
| (Fr) | Pediatric: 4.0, 5.0, 6.0 | |
| Adult: 6, 7, and 8 | 4.7, 6, and 8.4 | |
| Stent Length (cm) | Pediatric: 30 | |
| Adult: 70 | 125 | |
| Stent Material | C-Flex Thermoplastic Elastomer | Polyurethane |
| Stent Tip Configuration | Closed and Open Tip | Open Tip |
| Sideport Size (gage) | Unknown | 18, 19, or 21 |
| Stent Marker Band | ||
| Material | Unknown | Black Ink |
| Indwelling Time | ≤ 90 days* | ≤ 90 days |
| Packaging | Unknown | Tyvek polyethylene peel-open pouch |
| Sterilization | Unknown | EtO |
| Shelf Life | Unknown | 3 years |
*If information was not specified within the predicate 510(k), then information was obtained from currently available marketing information and is discussed further in the Substantial Equivalence discussion as appropriate. See AppendixF for predicate marketing data.
4
750 DANIELS WAY, P.O. B BLOOMINGTON IN 47402-0489 II 9 312 339 2235 TOULEREE: 800 457 WWW.COOKMEDICAL
The subject device, the Dretler Ureteral Diversion Stent Set is similar to the Percuflex™ Urinary Diversion Stent Set (K830803. Boston Scientific). The Dretler Ureteral Diversion Stent Set and the predicate are similar in that these devices have similar designs, intended use, and technological characteristics. The modifications from the predicate devices include:
- . A more specific indications for use
- Product Code ●
- Additional stent dimensions ●
- Characteristically similar material ●
- Unknown predicate materials
- Indwell time
- Packaging ●
- Sterilization ●
- . Shelf-life
Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified testing parameters on both subject devices. These tests include:
- MRI Safety Testing
- Dimensional
- . Tensile Strength
- I Shaft and Curl Elongation
- Retention Strength ■
- Flow Rate I
- I Radiopacity
- Kink
- Compatibility with components ■
- Artificial Urine Soak
- . Accelerated Aging
The Black Silicone Filiform Double Pigtail Stent Set manufactured by Cook Incorporated (K172017) was used as a reference device to help support a substantial equivalence determination for the Dretler Ureteroscopy Stent Set.
5
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold letters at the top. Below that, the word "MEDICAL" is written in white, smaller, bold letters.
COOK INCORPORATI 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Conclusion:
Packaging, sterilization, and shelf-life of the predicate device are not known, however, testing on the subject device has been performed on the subject device in accordance with all applicable standards and device requirements. The results of these tests show that the subject devices, Bander Ureteral Diversion Stent Set and Dretler Ureteroscopy Stent Set, met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the Bander Ureteral Diversion Stent Set is substantially equivalent to the predicate device the Percuflex™ Urinary Diversion Stent Set (K830803).
Furthermore, the results of these tests show that the subject Dreteroscopy Stent Set met the design input requirements based on the intended use. Therefore, these data support the conclusion that this device does not raise new questions of safety or effectiveness and that the subject Dretler Ureteroscopy Stent Set is substantially equivalent to the predicate device, the PercuflexTM Urinary Diversion Stent Set (K830803).
6
Indications for Use
510(k) Number (if known)
Device Name Bander Ureteral Diversion Stent Set
Indications for Use (Describe)
Used for intraoperative placement to stent the ureter and provide drainage from the external stoma during ureteroileal conduit construction and continent urinary diversions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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7
Indications for Use
510(k) Number (if known)
K181971
Device Name Dretler Ureteroscopy Stent Set
Indications for Use (Describe) This device is intended for post-ureteroscopy stenting of the ureter.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
Image /page/8/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 23, 2019
Cook Incorporated Paul Meyer Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K181971
Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set Trade/Device Name: Regulation Number: 21 CFR$ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: April 4, 2019 Received: April 5, 2019
Dear Paul Meyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls' provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
9
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure